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Aseptic Manufacturing Transfer Lead

2 months ago

Columbia, South Carolina, United States Integrated Resources, Inc ( IRI ) Full time

Title: Technology Transfer Manager

Location: Remote - Candidates must reside within 240 miles of Greenville, NC

Duration: 12 months+

Travel Requirement: Occasional travel to Greenville, NC, approximately once a month with short notice

Job Overview:

This fully remote position seeks a Subject Matter Expert (SME) in aseptic drug product manufacturing. The successful candidate will spearhead the coordination of activities necessary for transferring the drug product fill-finish process to the manufacturing facility. This process encompasses compounding, filling, and optical inspection. The individual will be responsible for leading intricate Technology Transfers and Process Performance Qualification initiatives that enhance the reliability and sustainability of our products at external manufacturing sites.

The role requires providing technical expertise and leadership to ensure the qualification of equipment, methodologies, hold times, and manufacturing processes align with the supply chain strategy. Collaboration with External Manufacturers and Pharmaceutical Innovative Medicine Quality, Planning, and Partnership & External Supply is essential. The team will ensure that processes are seamlessly integrated into the supply chain and that ongoing production consistently meets quality and regulatory standards.

Key Responsibilities:

  • Independently manage and execute complex projects requiring comprehensive analysis across multiple functional areas.
  • Facilitate effective communication within the core team.
  • Influence cross-functional teams and lead organizational efforts to achieve desired outcomes.
  • Travel to manufacturing sites as necessary to provide on-site support during qualification batch production.

The ideal candidate will possess expertise in biologic drug product manufacturing processes, with hands-on experience in Quality, R&D, and Manufacturing Operations being highly advantageous. Knowledge of process validation for pharmaceutical ingredients or products is also preferred.

Tasks and Responsibilities:

  • Lead complex technology transfers focusing on first-time execution and risk management.
  • Act as an SME to identify areas for technical and supply chain improvement.
  • Oversee drug product Process Performance Qualification and regulatory report preparation.
  • Support internal and external teams to ensure manufacturing site readiness and sustainability.
  • Provide SME input on complex investigations, root cause analysis, product impact assessments, and corrective and preventive action implementations.
  • Represent Pharmaceutical Innovative Medicine Supply Chain in interactions with external manufacturing partners.
  • Manage international sample shipments and execute shipping route verification studies per SOPs, supporting investigations and CAPAs as a technical expert in drug product manufacturing.
  • Review and approve batch records, validation protocols, data, and reports.

Required Competencies:

  • Proven experience in at least three of the following areas:
    • Project leadership
    • Pharmaceutical process development
    • New product introduction
    • Technology transfer
    • Process validation
    • Production support
  • Demonstrated technical competency in biologic drug products.
  • Experience managing technology transfers and/or Life Cycle Management projects.
  • Collaboration with R&D and Client groups to enhance product integration into the supply chain.

Personal and Interpersonal Skills:

  • Proven leadership in integrating activities and information across multifunctional teams.
  • Strong planning and logistics skills for effective deliverable integration at manufacturing sites.
  • Ability to foster team productivity and collaboration to achieve results.
  • Capability to influence and lead peers, superiors, and external partners, including senior management interactions.
  • Ability to work independently with a strong sense of prioritization and time management.
  • Capacity to manage complexity and adapt to change.

Personal Attitude and Mindset:

  • Self-motivated and proactive with demonstrated problem-solving abilities.
  • Driven to innovate and adapt to maintain competitiveness.
  • Possesses a results-oriented mindset that inspires the team.

Educational Background:

  • Engineer or Scientist with a Master's degree or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) and a minimum of 4 years of experience in biopharmaceuticals, or a Bachelor's degree with 8 years of experience.

Language Proficiency:

  • Fluent in written and spoken English.

Physical Requirements/Working Conditions:

  • Ability to work in an international environment across various time zones.
  • Willingness to travel approximately 25% of the time based on role requirements.
  • Utilize virtual networking tools to communicate with key partners and stakeholders.